A Phase I, Open-label, Randomized, 2-panel, 2-way Crossover Pivotal Bioequivalence Trial Between the Commercially Available 400-mg Tablet Formulation (F030) and the 800-mg Tablet Formulation of Darunavir (G002), in the Presence of Low-dose Ritonavir Under Fasted and Fed Conditions

Trial Profile

A Phase I, Open-label, Randomized, 2-panel, 2-way Crossover Pivotal Bioequivalence Trial Between the Commercially Available 400-mg Tablet Formulation (F030) and the 800-mg Tablet Formulation of Darunavir (G002), in the Presence of Low-dose Ritonavir Under Fasted and Fed Conditions

Completed
Phase of Trial: Phase I

Latest Information Update: 01 Sep 2014

At a glance

  • Drugs Darunavir (Primary) ; Ritonavir
  • Indications HIV infections
  • Focus Pharmacokinetics; Registrational
  • Sponsors Janssen R&D Ireland
  • Most Recent Events

    • 01 Jan 2013 Primary endpoint 'Drug-concentration' has been met.
    • 30 Jun 2011 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 01 Apr 2011 Status changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov.
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